Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus
Bavarian Nordic A/S
J07BX
smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
Other viral vaccines,
Smallpox Vaccine; Monkeypox virus
Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).The use of this vaccine should be in accordance with official recommendations.
Revision: 25
Authorised
2013-07-31
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER IMVANEX SUSPENSION FOR INJECTION Smallpo x and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IMVANEX is and what it is used for 2. What you need to know before you are given IMVANEX 3. How IMVANEX is given 4. Possible side effects 5. How to store IMVANEX 6. Contents of the pack and other information 1. WHAT IMVANEX IS AND WHAT IT IS USED FOR IMVANEX is a vaccine used to prevent smallpox, monkeypox and disease caused by vaccinia virus in adults. When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection in the form of antibodies against the smallpox, monkeypox and vaccinia viruses. IMVANEX does not contain smallpox virus (Variola) or monkeypox virus or vaccinia viruses. It cannot spread or cause smallpox, monkeypox or vaccinia infection and disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IMVANEX YOU MUST NOT RECEIVE IMVANEX: • if you are allergic or have previously had a sudden life-threatening allergic reaction to the active substance or any of the other ingredients of this medicine (listed in section 6) or chicken protein, benzonase, gentamicin or ciprofloxacin which may be present in the vaccine in very small amounts. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before receiving IMVANEX: • if you have atopic dermatitis (see sec Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT IMVANEX suspension for injection Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Modified Vaccinia Ankara – Bavarian Nordic Live virus 1 no less than 5 x 10 7 Inf.U * *infectious units 1 Produced in chick embryo cells This vaccine contains trace residues of chicken protein, benzonase, gentamicin and ciprofloxacin (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Light yellow to pale white, milky suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1). The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Primary vaccination (individuals previously not vaccinated against smallpox, mo_ _nkeypox or vaccinia _ _viruses) _ A first dose of 0.5 ml should be administered on an elected date. A second dose of 0.5 ml should be administered no less than 28 days after the first dose, see sections 4.4 and 5.1. _Booster vaccination (individuals previously vaccinated against smallpox, mo_ _nkeypox or vaccinia _ _viruses) _ There are inadequate data to determine the appropriate timing of booster doses. If a booster dose is considered necessary then a single dose of 0.5 ml should be administered, see sections 4.4 and 5.1. 3 _Special population _ Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox, monkeypox or vaccinia viruses should receive two boost Aqra d-dokument sħiħ